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Title:

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy

Abstract:

Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.

1. A pharmaceutical composition, consisting essentially of an aqueous solution of about 350-750 mg/ml sodium gamma-hydroxybutyrate, and a pH adjusting agent, wherein the pH
adjusting agent is malic acid, citric acid, acetic acid, lactic acid, carbonic acid, formic acid, propionic acid or tartaric acid, wherein the composition has a pH of about 6-7.5, and wherein the composition is chemically stable and resistant to
microbial growth, and wherein the composition is free of preservatives.

4. A pharmaceutical composition, consisting essentially of an aqueous solution of about 350-750 mg/ml sodium gamma-hydroxybutyrate, and a pH adjusting agent, wherein the pH adjusting agent is hydrochloric acid, phosphoric acid, sulphuric acid,
boric acid or nitric acid, wherein the composition has a pH of about 6-7.5, and wherein the composition is chemically stable and resistant to microbial growth, and wherein the composition is free of preservatives.

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